Initial Trial of Sanaria's Malaria Vaccine Yields Positive Results

ROCKVILLE, Md., September 08, 2011, 2011 /PRNewswire/ --
Positive results from the initial Phase 1 clinical trial in 80
healthy volunteers and complementary pre-clinical studies of the
Sanaria(R) PfSPZ Vaccine are published today in the online issue of
(www.sciencexpress.org).

"This is the first indication that a highly effective malaria
vaccine may be available that can be used to eliminate malaria in
geographically defined areas and prevent malaria in travelers,"
says Fred Binka, MD, PhD, Dean of the School of Public Health,
University of Ghana.

Medical science has long been on a quest for an effective
malaria vaccine. There are some 250 million malaria cases worldwide
annually, with as many as 800,000 deaths, most of them children in
Africa.

An effective vaccine that prevents malaria infection is
considered the only tool that will eventually conquer this disease.
Such a vaccine must prevent infection in greater than 80% of
recipients for 6-24 months in order to be suitable for elimination
campaigns and protecting travelers.

High level protection has only been achieved in humans who were
immunized by the bite of mosquitoes that inoculated live,
sporozoite stage parasites that had been weakened by irradiation or
drugs. Immune cells called cytotoxic or killer CD8+ T cells that
are activated by the sporozoites are responsible for the protection
against malaria after immunization with irradiated sporozoites.

It is not feasible to immunize large numbers of humans by bite
of mosquitoes carrying sporozoites, and it was considered
impossible to manufacture a sporozoite vaccine that met regulatory
standards.

"Therefore, despite the high level protection induced by
sporozoites administered by mosquito bite, before the breakthroughs
reported in the paper, no human had ever been immunized with a
sporozoite vaccine administered by needle and syringe," says
Stephen L. Hoffman, MD, Sanaria's Chief Executive and Scientific
Officer.

Sanaria has developed a unique manufacturing process that meets
FDA standards to produce the Sanaria(R) PfSPZ Vaccine. The vaccine
is composed of attenuated (weakened) malaria sporozoites that are
the stage transmitted to humans by mosquitoes.

The vaccine was tested by a team of biomedical scientists from
the U.S. Military Malaria Vaccine Program (Naval Medical Research
Center and Walter Reed Army Institute of Research); University of
Maryland Center for Vaccine Development; Vaccine Research Center,
National Institute of Allergy and Infectious Diseases, National
Institutes of Health; Sanaria Inc.; PATH Malaria Vaccine
Initiative; and Protein Potential, LLC. The principal findings and
conclusions reported in are:

Based on these results, the PfSPZ Vaccine administered by
intravenous injection will soon be assessed in a clinical trial at
the Vaccine Research Center, NIAID, NIH in the United States. A
trial in Tanzania is also being planned.

Professor Marcel Tanner, Director Swiss Tropical and Public
Health Institute, comments, "Sanaria has ushered in a whole new era
of malaria vaccine development and testing. We are heartened that a
path toward a vaccine that can be used to entirely prevent
infection with malaria has been established and will be rigorously
pursued."

Internationally renowned malariologist and vaccinologist
Professor Michael Good of Griffith University, Australia says, "The
results presented in represent an enormous step toward the
development of the highly effective malaria preventative vaccine
generally recognized as essential for the elimination and
eventually the eradication of the malaria scourge."

Sanaria Inc. was founded in 2003. The Company's mission is to
develop and commercialize whole-parasite malaria vaccines that
confer high-level, long-lasting protection against , the parasite
responsible for most of the malaria-associated severe illness and
death worldwide, and the other parasites that cause human malaria.
Sanaria's corporate headquarters, administrative, research,
development, and manufacturing operations are located in Rockville,
Maryland. The Company's website is http://www.sanaria.com.

Except for historical information, this news release contains
certain forward-looking statements that involve known and unknown
risk and uncertainties, which may cause actual results to differ
materially from any future results, performance or achievements
expressed or implied by the statements made. Such statements
include the availability of an effective vaccine, the expectations
for conquering malaria, beliefs concerning the suitability of a
successful vaccine, and the establishment of a path toward
prevention of infection. These forward-looking statements are
further qualified by important factors that could cause actual
results to differ materially from those in the forward-looking
statements. These factors include, without limitation, the
Company's ability to raise sufficient funds, the regulatory
approval process, dependence on third parties, clinical trials
results, the Company's patent portfolio, ability to commercialize
the vaccine, dependence on key personnel and other risks associated
with vaccine development.